510(k) K121295 ยท IYE Accelerator, Linear, Medical
ARTISTETM SOLUTION WITH SYS VCIO
| Applicant | Siemens Medical Solutions USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Apr 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121295
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2020 | Siemens Medical Solutions USA, Inc ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Terminated |
IYE | None listed |
| Mar 20, 2019 | Siemens Medical Solutions USA, Inc Siemens Digital Linear Accelerators of type:
ARTISTE MV System
MEVATRON M2/Primus Mid-Energy PRIMUS
PRIMUS HI
ONCOR Impression
ONCOR Impression Plus
ONCOR Avant Garde
ONCOR Expression
ARTISTE, ONCOR, Terminated |
IYE | None listed |
| Feb 14, 2018 | Siemens Medical Solutions USA, Inc ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912
Product Usage:
The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Terminated |
IYE | None listed |
| Jun 21, 2013 | Siemens Medical Solutions USA, Inc ARTISTE with syngo RT Therapist version 4.3
Product Usage:
The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for Terminated |
IYE | None listed |
| Mar 5, 2013 | Siemens Medical Solutions USA, Inc SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation O Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.